The Danish pharmaceutical company Bavarian Nordic wants to make its vaccine against mpox (monkeypox) available for adolescents aged 12 to 17. The company announced this on Friday. Bavarian Nordic has submitted an application to the European Medicines Agency (EMA) for this purpose.
Bavarian Nordic is currently the only pharmaceutical company that has a vaccine against mpox on the market. However, that vaccine, marketed in the European Union under the name Imvanex, is only approved for adults, while the recent outbreak also affects children. Therefore, the company wants to extend the license.
The company provides data from a clinical study involving 315 adolescents and 211 adults, which shows that the effectiveness of the vaccine remains unchanged and that the side effects are the same.
Bavarian Nordic hopes to obtain approval for vaccination of adolescents by the last quarter of 2024.
In addition, the pharmaceutical company is also preparing a clinical study for children between the ages of 2 and 12.
The World Health Organization (WHO) declared a global health emergency on Wednesday for the new, deadlier variant of mpox. The center of the outbreak is located in Congo. On Thursday, the first case in Europe was also reported in Sweden.
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Bavarian Nordic’s Push for Expanded Mpox Vaccination: Trends and Implications
The recent announcement by Bavarian Nordic to seek approval for its mpox vaccine, Imvanex, for adolescents aged 12 to 17 reflects a broader trend in public health: the urgency to protect younger populations against emerging infectious diseases. As vaccine development accelerates in response to global health crises, there is a growing recognition of the need to include adolescents and even younger children in vaccination campaigns, particularly in light of recent outbreaks.
Clinical data submitted to the European Medicines Agency (EMA) demonstrating the efficacy and safety of the vaccine in both adolescents and adults underscores a pivotal shift in how pharmaceutical companies approach vaccine licensing. This trend may lead to more comprehensive and inclusive vaccination strategies, especially as health authorities aim to prevent the spread of diseases that historically affected only specific age groups.
With the World Health Organization declaring a global health emergency due to new, more lethal variants of mpox, the urgency behind these developments cannot be overstated. This situation is emblematic of the broader challenges faced by global health systems in containing outbreaks while ensuring adequate protection for all demographics, including youths.
Furthermore, Bavarian Nordic’s preparations for clinical trials involving younger children aged 2 to 12 reinforce the idea that proactive measures are essential in combating infectious diseases. Expectation for the approval timeline suggests that public health policies will need to adapt rapidly, preparing for possible shifts in the new normal regarding vaccination protocols.
The vaccination landscape is evolving, with stakeholders increasingly advocating for the inclusion of younger individuals in vaccination initiatives. As Bavarian Nordic continues to push for regulatory approvals, other pharmaceutical companies may follow suit, potentially leading to a paradigm shift in how vaccines are developed and rolled out globally.